Gyno-Daktarin 20mg/G Cream
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S1720 LEAFLET Gyno-daktarin 20140327
PACKAGE LEAFLET: INFORMATION FOR THE USER Gyno-Daktarin 20mg/g Cream (miconazole nitrate)
Your medicine is known as “Gyno-Daktarin 20mg/g Cream” but will be referred to as “Gyno-Daktarin cream” throughout the following leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet
1. What Gyno-Daktarin cream is and what it is used for
2. Before you use Gyno-Daktarin cream
3. How to use Gyno-Daktarin cream
4. Possible side effects
5. How to store Gyno-Daktarin cream
6. Further information
1. WHAT GYNO-DAKTARIN CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is Gyno-Daktarin cream.
Gyno-Daktarin cream contains a medicine called miconazole nitrate. This belongs to a group of medicines called ‘antifungals'.
Gyno-Daktarin cream is used for infections of the vagina and the skin around the vagina. Signs of these infections include itching, redness and white discharge.
Gyno-Daktarin cream works by destroying the fungus that causes the infection and some of the bacteria which may also be present.
Your sexual partner may also need to be treated. Ask your doctor for advice.
About vaginal thrush
Vaginal thrush is a very common problem affecting women of all ages. It has nothing to do with poor hygiene. It is often caused by a fungus (Candida albicans) that is present in everybody.
The fungus is normally kept in check by the body's defences. Sometimes the fungus can become a problem due to:
• Recent use of antibiotics
• Pregnancy
• Use of oral contraceptives
• Wearing tight clothing
• Over use of hot baths and bath additives You can prevent infections coming back by:
• Washing the infected area in the morning and evening with plain, warm water. It is important that you dry thoroughly
• Wiping backwards (away from the vagina) after visiting the toilet
• Not using medicated and perfumed bath additives
• Not wearing tight clothing
2. BEFORE YOU USE GYNO-DAKTARIN CREAM
Do not use Gyno-Daktarin cream if:
• You are allergic to anything in the cream (listed in section 6 below)
Do not use this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Daktarin cream.
Take special care with Gyno-Daktarin cream
Check with your doctor or pharmacist before using this medicine:
• If you are using a ‘barrier' method of contraception. This includes condoms or diaphragms. This is because Gyno-Daktarin cream can damage the rubber and stop them working properly. Talk to your doctor about using another type of contraception while you are using this medicine
Do not allow other people to use your flannel or towel. This will stop them from getting your infection.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
In particular tell your doctor if you are taking:
• Medicines to thin the blood (anticoagulants) such as warfarin. Your doctor will need to check that the anticoagulant is working properly
• Medicines for diabetes, taken by mouth
• Medicines that act on the heart and blood vessels called ‘calcium channel blockers' such as dihydropyridines and verapamil
• Medicine for epilepsy called phenytoin
• Medicines to lower cholesterol called lovastatin or simvastatin
Tell your doctor before taking, or if you are already taking any of the above. They may need to alter your treatment.
Pregnancy and breast-feeding
Please tell your doctor before using Gyno-Daktarin cream if you are pregnant, think you may be pregnant or might become pregnant.
You may still be able to use Gyno-Daktarin cream if your doctor thinks you need to.
Talk to your doctor before using this medicine if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Important information about some of the ingredients of Gyno-Daktarin cream
• The cream contains benzoic acid and butylated hydroxyanisole. These can irritate your skin, eyes, eyelids, mouth and nostrils if they come into contact with them
3. HOW TO USE GYNO-DAKTARIN CREAM
Always use this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Using the cream
• Each tube of Gyno-Daktarin cream is sealed. You will need to use the cap to pierce the seal.
• Do not swallow the cream
For infections of the vagina
Your doctor may suggest treatment over 7 to 14 days:
• 7 day course - insert the cream into the vagina twice each day for 7 days
• 10 to 14 day course - insert the cream into the vagina once each day for 10 to 14 days
Your doctor will tell you how much cream to use and for how long
you should use it.
Inserting the cream with an applicator
• Remove the cap from the tube. Use the top of the cap to pierce the metal seal on the cap
• Screw the yellow end of the applicator with the green band onto the tube
• Squeeze the tube so that the applicator barrel pushes the plunger to the stop mark (figure 1)
1
• Unscrew the filled applicator and replace the cap on the tube
• Lie down with your knees bent and spread apart. Insert the yellow end of the applicator with the green band well into your vagina
• Push the plunger firmly but gently. Empty the cream into your vagina by pushing the plunger as far as it will go (figure 2)
• Remove the applicator and put it in the bin with your household rubbish
• Always wash your hands with soap and water after using the cream
• The cream does not stain your skin or clothes but you may want to use a sanitary towel
For infections outside the vagina
• Apply the cream to the affected area twice each a day
• Lightly cover the skin around your vagina with a thin, even layer of cream
• Always wash your hands with soap and water after using the cream
Your doctor will tell you how often and for how long to use the cream.
When to stop using Gyno-Daktarin cream
Keep using the cream until the course is finished, even during your period.
Do this, even if the redness, itching and discharge go away before the end of the course.
If you swallow Gyno-Daktarin cream
If a large amount of cream is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.
If you forget a dose
• Don't worry, apply the next dose of cream as usual and keep using the cream as your doctor has told you
• Do not use a double dose of cream to make up for a missed dose
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE GYNO-DAKTARIN CREAM
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use Gyno-Daktarin cream
• After the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month
• If the tube seal is missing or broken
• If the cream is not white in colour.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Gyno-Daktarin cream contains
• The active substance is miconazole nitrate. Each gram of cream contains 20mg of miconazole nitrate.
• Other ingredients are: tefose, labrafil, mineral oil, butylated hydroxyanisole, benzoic acid and purified water.
What Gyno-Daktarin cream looks like and contents of the pack
Gyno-Daktarin cream is available in a 78g aluminium tube with a white screw cap containing white smooth, homogenous cream and 16 single use applicators in a separate cardboard box contained in a carton.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Famar AEB, 49Km Avlonas, Greece.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gyno-Daktarin cream can cause side effects,
although not everybody gets them.
Stop using Gyno-Daktarin cream and tell your doctor straight
away if you notice the following. You may need medical
treatment.
• Severe irritation or reddening of the skin, swelling of the face, lips tongue or throat, light headedness, wheezing or difficulty breathing or other signs of allergy during the first few days of treatment. This only happens in a small number of people.
Other side effects:
• Local irritation (around or inside the vagina), itching or burning sensation of the treated area. This is much milder than an allergic reaction. Tell your doctor or pharmacist if these feelings continue
• Skin rash or hives (also known as nettle rash or urticaria)
• Stomach pain
• Low stomach pains (pelvic cramps)
• Headache
• Infection of urine or pain in passing urine
• Vaginal bleeding
• Feeling sick (nausea)
• Redness of the face
| POM | PL No: 19488/1720
Leaflet revision date: 29 April 2014
Gyno-Daktarin is a registered trademark of Janssen - Cilag.
S1720 LEAFLET Gyno-daktarin 20140429